Clinical trial · Interventional
Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
A Phase Ⅲ Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M (Docetaxel-PM) In Bacillius Calmette-Guerin Refractory Non-Muscle Invasive Bladder Cancer
NCT02982395CI-TRIAL-00040349terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitomycin-C | Drug | Mitomycin | ALIAS |
| Nanoxel®M | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nanoxel®M
- description
- 75 mg in 100mL normal saline
- interventionNames
- Drug: Nanoxel®M
- type
- ACTIVE_COMPARATOR
- label
- Mitomycin
- description
- 40 mg in 100mL normal saline
- interventionNames
- Drug: Mitomycin-C
Primary outcomes (1)
- measure
- Recurrence free rate
- timeFrame
- 1 year
- description
- Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy. Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of superficial transitional cell carcinoma of the bladder (Ta, T1) * Recurrent superficial bladder cancer refractory to Bacillus Calmette-Guerin (BCG) * No previous intravesical therapy for 6 weeks * No history of prior radiation to the pelvis * Peripheral neuropathy ≤ grade 1 * Eastern Cooperative Oncology Group (ECOG) performance status 0 t0 2 * Adequate hematopoietic and hepatic parameters Exclusion Criteria: * Muscle invasive disease (T2-T4) * Any other malignancy diagnosed within 2 years of study entry (Except basal or squamous cell skin cancers or noninvasive cancer of the cervix) * Participation in any other research protocol involving administration of an investigational agent within 3 months before study entry * History of sensitivity reaction to docetaxel * Prescribed immunosuppressive medications because of a confounding medical condition * Female patients who were pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.